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GRM Warfare

Denise Caruso's new column at the New York Times kicks off with an essay on patents in the world of biotechnology. Most of the piece looks at how to build an intellectual property regime for biotechnology that serves the interests of society, not just a handful of companies. She cites a troubling, if not surprising, statistic: more than 20% of the human genome has already been patented, mostly by corporate biotech.

She also mentions the case of genetically-modified potatoes from biotech firm Syngenta. Not only are the GM spuds patented, they've been modified to be sterile without the application of a particular chemical. Potato farmers can't "copy" the crop without paying a fee.

The combination of these two facts is frightening. She doesn't use the term, but it's very clear as to what's going on here:

Genetic Rights Management.

Genetic Rights Management (GRM) is copy-protection for genes, a direct parallel to Digital Rights Management for CDs, DVDs, and other media. It's a term I came up with in 2002, as I was writing Transhuman Space: Broken Dreams. It's a way of preventing the duplication of patented genetic modifications by preventing unlicensed reproduction of individuals bearing those genes. It was an idea that struck me as the nearly-absurd but utterly plausible extension of trends in both biotech and intellectual property law; it now appears to be another case of successfully predicting the present.

Biotech companies are unlikely to successfully put GRM onto naturally-occuring human genes that they have patented. They'll try, but it seems likely to be a legal loser; despite the current situation of biotech companies having a strong monopoly on the genes they patent, ownership of one's own naturally-occuring genes is a sufficiently common-sense notion that, even if the courts upheld the patent rights, legislatures are likely to jump in to fix the laws. Biotech companies will be on firmer ground if they GRM-protect genemods that do not naturally occur in human beings, but can be used as a genetic treatment or enhancement.

The tools to make this possible already exist. One way would be through the use of Human Artificial Chromosomes (HACs). Bacterial genetic research often uses artificial chromosomes inserted into a bacterial nucleus, allowing researchers precise control over the placement and replication of the new genes. The same is possible with human biology, giving a cell which would normally have 46 chromosomes an extra, 47th, micro-chromosome with a small number of DNA base pairs. Case Western scientists reported the development of HACs in 1997, but the technique is not known to be in common use at this point. HACs would make the application of genetic rights management simple, either by applying the genemod directly via the artificial chromosome, or by putting the control mechanism in the HAC.

The notion of introducing sterility in a genetic modification recipient to prevent unlicensed duplication is a staggeringly awful idea, yet is the logical result of current practices. Human genes are, as Denise Caruso describes, already subject to strong patent rights.

As Tim Hubbard, a Human Genome Project researcher, noted at a 2001 conference: “If you have a patent on a mousetrap, rivals can still make a better mousetrap. This isn’t true in the case of genomics. If someone patents a gene, they have a real monopoly.”

This monopoly gives patent holders total control over patented genetic materials for any use whatsoever — whether for basic research, a diagnostic test, as a test for the efficacy of a drug or the production of therapies.

It may be that GRM goes too far, and that any attempt to roll out such a system will result in backlash against the underlying notion of genetic patents. I hope so, at least; already, too much of what had been in the commons has been locked up as private intellectual property. But as we work to raise awareness of and resistance to overreaching by big bio, we need to recognize that things are not nearly as bad as they might yet be.

Comments

I just wanted to clarify what is meant by a "gene patent". Here is a some reasonable summaries:

http://biotech.about.com/library/weekly/aa060900a.htm

http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml

Essentially, what you can patent is the novel use of a protein, or the inclusion of natural DNA in an artificial construct -- a "recombinant molecule". But you cannot patent a gene, per se, because no human invention was required to come up with the molecule.

Thus both the title of Caruso's piece, "Someone (Other Than You) May Own Your Genes", and the quotation, "More than 20 percent of human genes have already been patented, and most of those patents are owned by corporations," are somewhat misleading.

It is certainly true that, as Caruso notes, we need to have, "A more democratic and inclusive conversation about intellectual property concerns as biotech marches on." Overpatenting is a clear threat to innovation of all kinds. But in order to be useful and relevant, the discussion of how to move forward needs to hew closely to legal, technical, and scientific realities.

Phrasing the issue as "Uses for 20% of human genes have been patented..." would be somewhat less alarming, and (from what these links describe) more accurate.

What seems to bother people in particular are examples of patents overreaching -- trying to claim more than is appropriate within custom and law -- and patents on the use of genes/gene fragments/proteins derived from an individual's genome. That is, something in my genes codes for an unusual protein or process, and a treatment derived from and using that genetic code & protein gets patented -- but although it comes from something in my body, somebody else owns the patent. While that makes sense abstractly, it is ethically troubling for many people.